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The misplaced Avandia hysteria
Lawyers are already circling like sharks over the recent concern about the drug rosiglitazone (brand name Avandia, produced by Glaxo-SmithKine) for treatment of type 2 diabetes was precipitated by an early press release of a paper (Nissen and Wolski, 2007. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. New England Journal of Medicine 356:2457-2471) over three weeks before its actual publication date, which was yesterday (June 14). This means yesterday was the first day any of us except the reviewers of the paper and editors of the New England Journal of Medicine has had a chance to evaluate the actual data, rather than statements made by the authors and editors. Congressional hearings, at which a doctor said he was pressured by Glaxo-SmithKline not to reveal his concern about Avandia's safety, were underway well before this publication date.
Meta-analyses are studies that statistically analyze the results of all previous trials together to see if there is an overall trend that was not picked up in each individual trial. What the authors of this meta-analysis are saying is that based on 42 different trials that were done at various times, for different reasons, people taking Avandia are more likely to have heart attacks than people not taking it. There are several statistical problems with meta-analyses, but the authors did the best they could, using a test that should provide reasonably accurate results with the data they had, in which heart attacks were rare.
To put it that rarity in perspective, their data overall showed that for a minimum 24-week period, 86 out of 15,565 diabetes patients taking Avandia had heart attacks, versus 72 out of 12,282 not taking the drug (this was a hodge-podge pool consisting of placebo groups, and groups taking various other diabetes drugs). This translates to 0.55% (5.5 out of a thousand) of those on Avandia having heart attacks, and 0.59% of those not on Avandia having heart attacks -- a slightly higher percentage. Of course, in a proper meta-analysis one cannot simply pool all the numbers and re-analyze them together. The statistical procedure the authors used did reveal a higher risk of heart attack in the group taking Avandia, but the difference remains slight.
One fallacy people commit in statistical analyses is to believe that the larger the data set, the more meaningful the result is. But in general, the opposite tends to be true. This is because the only way the authors could find a (barely) statistical difference in the two groups was to have a sample size of nearly 28,000. If you need a sample size that big to find a real difference between the two groups, the difference is not nearly as serious as if you had found it in a sample of a few hundred people. One gets the distinct impression that this paper was a fishing expedition, an impression that is not undermined by the disclosure that the first author receives research support from the following seven drug companies that are not Glaxo-SmithKline: Pfizer, AstraZeneca, Daiichi Sankyo, Roche, Takeda, Sanofi-Aventis, and Eli Lilly.
What makes the potential hysteria surrounding this drug especially egregious is the unscrupulous press release and author interviews three weeks ago that did not reveal the unbalanced sample sizes of the two groups:
In their analysis, Nissen and Wolski pooled data from 42 studies that have been conducted on the drug. Among more than 27,843 patients in the relatively brief studies, 86 of those taking Avandia had a heart attack, compared with 72 of those not taking the drug.
The implication of course is that overall, more people taking Avandia had heart attacks when that is absolutely false.
But even assuming the results are completely valid, there is still the huge problem of the lumping of people with all sorts of medical history in these groups. The authors state themselves in the discussion:
The FDA-approved rosiglitazone product label reports a mean increase in low-density lipoprotein (LDL) cholesterol of 18.6% among patients treated for 26 weeks with an 8-mg daily dose, as compared with placebo.
This of course means that if you have a problem with high cholesterol, this drug is not for you, but your doctor knows this already. But what were the cholesterol levels and heart conditions for those having heart attacks in the meta-analysis? It is completely unknown.
Admittedly, the authors did not have access to most of the original data sets, many of which came from Glaxo-SmithKline clinical trials (though one has to wonder if they tried asking the company for the data), which means they cannot present a breakdown of heart attack victims by a priori risk. But presenting these results without that data is at best irresponsible. It has become very much clearer over time that individuals vary and a particular drug that works wonders for one person might be fatal for another. The implication of the congressional hearings and media coverage of this one paper with its weak result is that we are going to make the decision to keep that drug from those that it will benefit, rather than take the trouble to learn enough to figure out which few people will be harmed by it, and keep them off of it.
Labels: health, humans, statistics
posted by Biotunes at
2:56 PM
1 Comments:
Admittedly, the numbers aren't particularly impressive, but we're talking about 5 (rounding down from 5.5) deaths occurring because of an appearance of relationship with Avandia.
I took Avandia for a year and a half before stopping WITHOUT my doctor's okay. Why? Several trips to the emergency room with symptoms of heart failure, one of which led to a heart cathaterization, which turned out to be a big sigh of relief for me, despite the consent forms that warned about possible death due to the procedure alone. A sigh of relief? Sure. The procedure revealed I had no blockage to the arteries of my heart despite weighing in at over 280lbs, and living in that range for 7-8 years on top of a lifelong unhealthy lifestyle. Aparently my body processes cholesterol a lot differently that many other not-so-fortunate people.
But to the point. Less than two weeks after tossing out the Avandia my symptoms were gone, and have not returned. I've been stress-tested recently as well, and everything's fine. I'm the fortunate one. 5 others, however, were not so fortunate (assuming those five are the result of the drug and not their own poor health). That's FIVE families who have lost loved ones.
I don't believe it's fair to categorize the debate against Avandia as 'hysteria'.
For myself, I'm almost off ALL diabetes medication. My pancreas is beginning to work the way it should after 5 or more years of being incognito-- I was tempted to say 'derelict in its duty' but that would be unfair. It was my own lifestyle that forced my pancreas, liver, kidneys and assorted other internal functions to stop functioning properly... I did it to myself.
I came to the following statement after much thought, research, and study: Modern Western medicine can't really cure anything. It only knows how to 'Treat'. Something else I've learned: I am responsible for my own good or poor health. The choices I make determine my future. The human body cannot by it's very nature do anything wrong. The body merely responds to the conditions it finds within itself, be it a weakened immune system, a tired kidney, leukemia... the body always seeks to find a workable balance to whatever problems exist within its 'sphere of influence'. Give your body what it needs to function properly (which does not mean synthetic drugs), and provided the damage is not too overwhelming or widespread, the body can and will repair itself.
Four years ago I would have taken a doctor at his/her word without question... because he/she is a doctor. Not anymore. I have learned that for Type 2 patients, Diabetes is not so much a disease that can't be cured than it is a laundry list of 'symptoms' the body has put in place to 'manage' the problem of high blood sugar. The sad part in all this is Western medicine, as well, seeks only to 'manage' diabetes.
Has anyone bothered to wonder why diseases are so rampant in America today? Is it simply because we have better tools with which to diagnose and record cases? I don't believe so. It is my firm belief, and conviction, that America suffers... the West suffers... because of our poor diet. Ever pick up a box of Hamburger Helper and read the list of ingredients? What are all those ingredients!? It's terrifying what this nation is doing to itself.
Diabetes CAN be cured... NOT For all!... but for many it can be cured. But few in the medical profession seem to either WANT to cure their patients, or want to take the time to convince their patients they CAN be cured-- Americans are so very stubborn.
I've changed my diet 180 degrees, and it has NOT been easy. Nothing that comes from a box, and nothing that has been processed beyond it's natural state. Organic for the most part. And expensive! But I figure, better to pay the farmer and health food store now, than pay the doctors and specialists later.
If any hysteria exists, it's in the medical professions assertion that vitamins, minerals, and raw healthy foods can't cure anyone of anything. I've met plenty of them, and they've all been wrong. Simple truth is, give the body what it needs (not synthetic drugs like Avandia) and it can repair itself... Even cancer can be effectively destroyed if the immune system is strong, and the body has what it needs. You don't use a jackhammer to unstop a toilet. In the same manner, Avandia and other drugs will certainly alleviate the symptoms, for a time-- until things worsen and more symptoms rear their ugly heads --but they are largely synthetic, and the body doesn't know how to process them. The liver ends up taking the brunt and when the liver gives out... Do we really want to wait for someone else to die just get a liver replacement? Diabetes becomes the least of ones worries. Besides which, Diabetes, according to all my research and study, appears to BEGIN in the liver. Which is curious to me since all modern medications tend to do these days is gum up the liver even more.
For a bit of context into my position here, you can read my own posts on Avandia here, and here.
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